Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

Recall date
May 12, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1964-2025
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US Nationwide distribution.

Why it was recalled

Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

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